“LGM operates as a trusted partner by seeking out optimal source of APIs for clients”
This week, SpeakPharma interviews Selwyn Lustman, Senior Vice President, Global Sourcing and Procurement, LGM Pharma, a tailored active pharmaceutical ingredient (API) and contract development and manufacturing services provider (CDMO) for the full drug product lifecycle. Lustman discusses the kind of regulatory support LGM provides its clients, while also talking about its methodology for selecting the optimum source of APIs for its clients. Excerpts:Can you briefly take us through the history of LGM Pharma?We were established in 2005, and since inception we have been on a dedicated mission to excel in the sourcing and distribution of top-tier APIs, offering comprehensive API supply chain solutions spanning R&D to commercialization.In 2020, LGM Pharma acquired the formulation development and drug product manufacturing business of Nexgen Pharma, Inc. This acquisition merged LGM’s global leadership in API sourcing, distribution, and supply chain management with Nexgen Pharma’s comprehensive drug product CDMO services.What are some of the risks involved in sourcing APIs? And how can drugmakers manage these risks?The primary challenges associated with API sourcing encompasses quality and regulatory considerations, necessitating the assurance of a material source aligned with the specific quality and regulatory standards applicable to the ultimate dosage product launch.Efficient supply chain distribution hinges on establishing a collaborative partnership with a manufacturer capable of seamlessly supporting the entire spectrum, from early research and development (R&D) stages to the culmination of full-scale commercialization.Price considerations also come to the fore, demanding that the chosen manufacturer not only meets but surpasses safety, environmental, and health requirements. Working with a seasoned sourcing partner serves as a proactive measure to mitigate these risks, as such a partner brings forth invaluable expertise to navigate the intricate landscape of regulatory and quality guidelines.What kind of regulatory support do you provide your clients?LGM Pharma offers a comprehensive suite of regulatory expertise to its clients, encompassing a spectrum of critical services. This includes evaluation of active substances and the meticulous technical writing and compilation of US Drug Master Files.Throughout the development process, LGM provides expert regulatory CMC (chemistry, manufacturing and controls) compliance guidance, overseeing the writing and assessment of quality/CMC regulatory documents (Module 2 and 3).LGM Pharma ensures seamless coordination with clinical trial partners to guarantee eCTD (electronic common technical document) compliance (Module 5) and conducts critical writing and reviews of drug substance and drug product documentation.LGM’s commitment extends to adherence to Code of Federal Regulations and guidance documents, ensuring the timely approval of new abbreviated new drug applications (ANDAs), amendments, and post-approval changes.LGM Pharma also exhibits agility in responding to inspection requests (IRs) and commitment resolutions (CRs) prior to due dates, engages in regulatory authority interactions, including serving as a US agent, and conducts regulatory compliance gap analyses with adept issue resolution. Additionally, LGM conducts scientific, regulatory, and due diligence review of regulatory documents and submissions, reinforcing its commitment to regulatory excellence.LGM Pharma has a strategic approach to API sourcing. Can you throw some light on this approach, and its benefits to your clients?LGM Pharma distinguishes itself from conventional distributors by adopting a unique approach – one that sets it apart in the industry. Unlike distributors aligned with specific API manufacturers, LGM takes on a consultative role, prioritizing the representation of its clients’ interests.Operating as a trusted advisor, LGM actively seeks out the optimal source of API for clients to serve as their primary drug substance supplier. In contrast to distributors affiliated with particular manufacturers, who inherently advocate for their associated companies, LGM positions itself as an unbiased entity capable of objectively confirming the selection of the best manufacturer. This client-centric approach ensures a discerning and tailored choice in the dynamic landscape of pharmaceutical ingredient sourcing.What role does logistics play in API sourcing? How does LGM Pharma help out its clients with regulatory compliance?Logistics plays a critical role in API sourcing, influencing the efficiency, reliability, and regulatory compliance of the supply chain. LGM Pharma, as a specialized pharmaceutical ingredient supplier addresses these logistics challenges in the following ways:- Supply chain management: LGM is involved in managing the end-to-end supply chain, ensuring the timely and secure movement of APIs from manufacturers to clients. This involves coordinating transportation, handling custom clearance, and optimizing inventory levels to prevent disruptions to the supply chain. - Quality assurance in transportation: Given the sensitivity of pharmaceutical APIs, LGM implements stringent quality assurance measures during transportation to maintain the integrity of the APIs. - Regulatory compliance: LGM assists clients in navigating the complex regulatory landscape associated with API sourcing. This includes adherence to GMP regulations, compliance with international standards, and ensuring that the transportation and storage of APIs meet regulatory requirements. - Documentation and record keeping: LGM maintains detailed documentation related to the transportation and handling of APIs, facilitating regulatory audits and compliance checks. Accurate record-keeping is essential for demonstrating compliance with regulatory guidelines. 

Impressions: 2327


#SpeakPharma with LGM Pharma
13 Dec 2023
“Our Translational Pharmaceutics platform shortens drug development timelines by over 12 months”
This week, SpeakPharma interviews John McDermott, Vice President of Scientific Consulting at Quotient Sciences, a drug development and manufacturing accelerator. McDermott highlights how pharma and biotech companies can leverage Quotient’s integrated services to improve the development of small molecule therapeutics in oncology. He discusses benefits of evaluating targeted oncology molecules in healthy volunteers, and how Quotient Sciences has applied its Translational Pharmaceutics® platform to accelerate drug product optimization. Excerpts:Tell us about Quotient Sciences’ experience with oncology drug programs.There is a growing demand for new and improved oncology treatments and it is important to streamline drug development processes so that new treatments can reach those in need.Over the last decade, Quotient Sciences has delivered over 400 projects with oncology drugs. This includes over 80 clinical programs with healthy volunteers. These clinical programs include first-in-human single-ascending-dose/multiple-ascending-dose, relative bioavailability, and 14C human absorption, distribution, metabolism, and excretion (ADME) programs.Using our flagship platform for drug development — Translational Pharmaceutics® — we are able to integrate drug substance synthesis, drug product and clinical testing activities within a single provider. This integration removes the white space that traditionally exists between these functions.By deploying Translational Pharmaceutics®, we are able to reduce development timelines by 12 months or more. This way, we are able to help our global pharma and biotech customers minimize risks while saving time and costs.Can you explain how Translational Pharmaceutics reduces the drug development timeline?Translational Pharmaceutics® allows the time between drug product manufacture and clinical dosing to be reduced from months to days, thereby reducing hold times whilst also enabling a ‘real-time’ approach to manufacture, as driven by clinical need.Recently, an oncology program of a customer involved accelerated conduct of a first-in-human study. The investigational drug was poorly soluble. In just 12 months, we were able to develop multiple formulation options to overcome the solubility limitation, and switch development to a product suitable for chronic administration in patient trials.What are some of the challenges with accelerating new drug application (NDA) timelines?The ongoing battle against cancer requires novel approaches to accelerate the clinical trial process. Accelerated approval pathways, which allow the NDA application process to commence from phase 2 onwards, require early submission of a high-quality chemistry, manufacturing, and controls (CMC) package. This push to expedite timelines only increases the risk of commercializing a drug substance and drug product production process that is not fully optimized or scalable.Our approach involves an early understanding of the biopharmaceutical properties of the drug early in the development process, combined with expertise in process chemistry, analytical technology, and formulation development. By gaining early insight into the compound’s druggability, we mitigate risks in subsequent development phases.Application of Translational Pharmaceutics® to support formulation screening and optimization of drug product allows us to ensure rapid and flexible delivery of scalable drug products that meet the therapeutic need. This guarantees a high-quality CMC package that aligns with the accelerated approval process for oncology trials.How has Quotient Sciences used healthy volunteer clinical trials in oncology?We’re increasingly seeing that emerging modalities such as immunotherapy and new chemical entities (NCEs) are presenting challenges in terms of physical form, morphology, and chemical complexity.Drug product optimization is a crucial step to ensure downstream clinical success in patients. In this process, drug developers may look to increase oral bioavailability and solubility, reduce pharmacokinetic (PK) variability, overcome food effects, avoid adverse events, and reduce dosing frequency by switching administration routes or by switching to a modified-release form.For oncology drug programs, these challenges can be magnified, as dosing is typically performed directly in patients in phase 1, rather than by conducting healthy volunteer studies to establish safety and PK data. The approach of going directly into patients is known to be inherently problematic when it comes to the speed and effectiveness in identifying improved formulations to deliver improved PK profiles.The Translational Pharmaceutics® platform removes the white space in development by enabling real-time drug product manufacturing to be integrated with clinical assessments, reducing stability data requirements and batch sizes, and accelerating program delivery.Under Translational Pharmaceutics®, drug products can be manufactured, released, and dosed in days. Rapid access to real-time human clinical data from one study period determines the formulation composition that is then made and dosed in the next. We’ve found that studying oncology molecules in healthy volunteer studies, where safe to do so, can often mean that study recruitment is not as complex. It can be achieved faster, and cohorts can be dosed together to improve formulation decisions. This also reduces or completely removes the variability in clinical data due to disease state. Moreover, the studies become more cost-effective to conduct. 

Impressions: 1309


#SpeakPharma with Quotient Sciences
07 Dec 2023
“Communication is crucial, experience pivotal for outsourcing life science marketing”
This week, SpeakPharma interviews Kate Covalt, Vice President, Client Services and Executive Strategist at SCORR Marketing, a leading full-service marketing and communications firm in the health sciences space, who throws light on the benefits of outsourced marketing support. According to Covalt, communication and collaboration are key, as is selecting an experienced and strategic agency partner. What are the benefits of outsourcing marketing, as against building an in-house team? An objective, outside perspective is an invaluable asset. Being too close to something, like our own business, can create a “curse of knowledge” bias that prevents us from seeing other solutions or being open to exploring them. An outside perspective can ignite fresh ideas and shed light on gaps in current strategies or approaches. Agencies also come armed with a breadth of experience on running campaigns across a wide variety of channels, and provide insight into what’s working, what’s not, and what’s new. That compounded knowledge is a noteworthy benefit. Additionally, it can be more cost-effective to outsource marketing. Think about the overheads that go into building a robust internal team — salaries, health benefits, PTO, management of employees, etc. It all adds up. With an agency, you get an entire marketing team without the burden of overheads and management expenses. Moreover, you get the added bonus of being able to work with experts across key areas: strategists, SEO, social media, PR, copywriting, design, etc. If a company already has a marketing team, why would they outsource additional support? The hybrid approach provides specialized expertise and support to complement a company’s internal team. You never want a lack of time or resources to inhibit business growth or prevent you from hitting your marketing goals.  Bringing on an agency helps prevent this. A hybrid approach can also be very customizable and flexible. It allows a company to scale its marketing team up and down to meet their current needs or budget while tailoring outsourced work to fill internal gaps or to address specialization. How can companies with an internal team and external support ensure alignment on strategy? Great question. First of all, find an agency that puts strategy first — one that fundamentally believes strategy drives creative, and not the other way around. Those agencies will likely already have an approach in place that sets the two organizations up for alignment. Apart from that, communication is crucial. Be sure to establish clear communication channels and share your business goals. Make planning an integrated and collaborative process. Effective and strategic marketing plans can’t be developed in a silo. Clear communication of objectives is essential so that everyone is working towards a common purpose. It is also important to ensure both teams have access to data and analytics. Marketing isn’t a set-it-and-leave-it activity. Therefore, this collaboration needs to be ongoing and proactive in order to build trust. Consistent feedback loops help identify what is working, what isn’t, and how to pivot accordingly. How important is it to work with a partner with experience in the industry? It definitely has an upside. You wouldn’t hire a marathon runner to coach you in sprinting simply because she knows how to run. Context is important, and an agency partner with industry experience has already collected a lot of that context. It’s not just about hiring an expert, it’s about hiring the right expert. If you partner with an agency with a foundation in the industry, you will be able to focus your valuable time on sharing insights around the nuances and goals of your unique business. This ultimately translates into spending a lot less time and money educating your partner, and getting time to focus on solutions to get your business closer to its goals, faster. While looking for the right agency partner, what are some key questions one must ask an agency? Start with the basics. What is the agency’s experience in the industry? What is the breadth of services it offers? How big is their team, and how many of those are full-time employees? Is the work all done in-house or does the agency have partners they outsource work to? Beyond that, it is important to understand how the agency operates and what you can expect as a client. What is the agency’s approach to strategy and creative development? How does their team define success and how do they report on it? How does the agency manage client communication and collaboration? How often can you expect updates, and is there a designated point of contact? What is the pricing structure and how does the agency handle changes in scope? You should also get a sense of culture. You will be working closely with the agency’s team, so meet and talk to them. This really needs to be a two-sided conversation. There is no “silver bullet” in marketing. Therefore, make sure you’ll be working with an agency that is truly solution-oriented, and that there is a strong alignment of values and philosophy. What can companies do to set themselves up for success in their marketing partnerships? It is essential to invest in developing a strong relationship with the team. That foundation of trust will ultimately create a more open, creative, and transparent environment — and that’s the kind of environment that marketing teams flourish in. Again, communication is key. Establish clear goals, communicate when those goals change, be transparent with expectations, and always begin with strategy.

Impressions: 7493


#SpeakPharma with SCORR Marketing
31 Oct 2023
“We are working towards providing affordable, high-quality APIs”
This week, SpeakPharma interviews Dr. N.V. Rao, Chairman and Managing Director of Hyderabad (India)-based Metrochem API, one of the fastest growing manufacturers of active pharmaceutical ingredients (APIs), pellets and intermediates. Dr. Rao talks about Metrochem API’s strong core values and how the company has put in special efforts to meet the needs of the under-cared and neglected communities, with a clear view on sustainable health for all. Excerpts:Can you briefly take us through Metrochem API’s journey? When we embarked on this extraordinary journey in 2004, armed with my expertise in organic chemistry, our vision was unwaveringly clear. We aimed to establish a company that would manufacture top-tier APIs of exceptional quality, all while maintaining cost-effectiveness. Our goal was to cater to the pharmaceutical industry's global needs and position Metrochem as the premier supplier of APIs to customers worldwide. Since our inception, we've strongly believed in creating value through vertical integration. This belief has driven us to continuously invest in infrastructure and manpower, ensuring an abundant supply of key starting materials (KSMs), intermediates, and essential raw materials. Our six state of the art manufacturing facilities are designed and operated in line with this risk mitigation vision. We consider ourselves a pure-play API manufacturing company with an acute awareness of the technical challenges facing the healthcare industry. Our focus has always been on expanding our product portfolio to meet the diverse demands and challenges of the global landscape. We've successfully built a robust product portfolio comprising over 190 products spanning more than 30 distinct therapeutic segments. We excel in handling a variety of niche products that require intricate chemical processes and pose significant challenges, elevating them beyond the typical niche category. Metrochem's journey, from my perspective, has been a relentless pursuit of excellence, innovation, and a commitment to serving the global pharmaceutical industry with integrity and dedication. What are some of the key reasons behind Metrochem API’s success?Our success is credited to our culture, which is founded on innovation, integrity, customer-centricity, and safety. These principles guide every Metrochem team member, and we take immense pride in consistently exceeding expectations.At Metrochem, our organization's foundation is built upon our core values, which we affectionately refer to as "LEADER." Within this framework, 'L' signifies our dedication to 'Learning aspiration,' 'E' embodies our perpetual pursuit of 'Excellence,' 'A' represents our 'Action-oriented' approach, 'D' symbolizes our commitment to 'Discipline,' 'E' underscores our steadfast dedication to 'Ethics and integrity,' and 'R' stands for 'Respect.'We maintain a strong commitment to ethical behavior and actively pursue our social responsibilities. We extend respect to every individual, and consider our stakeholders cherished members of our extended family. Building meaningful relationships with our customers, colleagues, and suppliers is an integral part of Metrochem's identity. These values are deeply ingrained within Metrochem, and guide our daily operations.This robust value system drives our passion for continual growth and self-improvement, both on an individual and at an organizational level. Our enthusiasm is channeled towards achieving operational excellence, with a primary focus on innovation and cost efficiency, all while upholding unwavering quality standards.How has your manufacturing setup grown over the years? Which regulatory authorities have recognized your efforts?Our journey began with a single API facility in Hyderabad, accredited with WHO-GMP, where we initially manufactured two APIs. By 2009, this facility had successfully met the rigorous regulatory standards set by the Pharmaceutical and Medical Devices Agency (PMDA) in Japan. In subsequent years, we not only maintained our WHO-GMP accreditation but also earned recognition from the US Food and Drug Administration (FDA) and COFEPRIS (Mexico Health Authority) in 2013. In 2014, we obtained accreditation from the Korea Food and Drug Administration (KFDA), which is now known as the MFDS (Ministry of Food and Drug Safety).We prioritize adhering to strict regulatory compliance standards. Our commitment is demonstrated through our willingness to undergo regular inspections by esteemed international and national regulatory authorities, including the USFDA, PMDA, WHO-GMP, ANVISA (Brazilian health regulator), and the European Directorate for the Quality of Medicines and Healthcare (EDQM), among other reputable bodies. These recognitions have played a pivotal role in elevating our position as a leading bulk drug manufacturer in India.We are grateful for the regulatory progress we have achieved over the years. At present, Metrochem has submitted 56 US Drug Master Files (USDMFs), 21 Certificates of Suitability (CEPs), and numerous other significant regulatory filings. Notably, we earned the global top ranking for the number of API USDMFs filed in 2022.We currently operate with six state-of-the-art manufacturing facilities located in the states of Telangana and Andhra Pradesh, boasting of a total reactor volume exceeding 3000KL. These manufacturing plants are backed by three cutting-edge, centrally located research and development laboratories, along with a pilot plant designated for testing and development purposes.What are Metrochem API’s target markets? How do you contribute towards sustainable healthcare?Currently, we are fulfilling pharmaceutical needs across over 60 countries. Unlike the typical focus on developed markets, our dedication extends to addressing healthcare inequalities not only in developed markets but also in the underserved, marginalized communities, and less developed nations. Our overarching vision centers on promoting sustainable access to healthcare for everyone.Our partners often say that “quality and affordability go hand in hand at Metrochem”. This has been possible due to our vertically integrated supply chain and our robust manufacturing process that we establish during the initial stages of product development. These processes allow us to not only match the desired specifications of our customers but also give us ample space to stay reasonable in terms of pricing, without hampering the quality standards.We have a wide-reaching market presence that covers diverse geographical regions, including India, the United States, Europe, South East Asia, the Middle East, Africa, Latin America, as well as Asian countries like Japan, Korea, China, Pakistan, Bangladesh, Nepal, and Sri Lanka. Our goal is to transform into a multinational company, from being a multi-state player, in the near future by setting up centers in crucial global locations. This strategic move will give us a substantial advantage in expanding our global presence and operations.We acknowledge our responsibility in promoting global health equity, which serves as a driving force for us to continuously enhance access to life-saving medications worldwide by aligning with varied rigorous delivery schedules.What are Metrochem API’s growth plans?Our objective is to become the foremost choice as an API supply chain partner. We plan to broaden our customer base through exceptional product quality and delivery services. At the same time, we aim to strengthen our global reputation as the most respected API partner,  while diversifying our product portfolio to include candidates among varied therapeutic segments.In addition to having a product portfolio covering 30 different therapeutic segments, we have taken steps to enter the field of oncology by establishing a dedicated facility for the production of oncology APIs. Furthermore, we plan to start manufacturing steroids and peptides soon. Our vision includes expanding into biopharmaceutical manufacturing within the next five years, all while maintaining our commitment to core small molecule API production.Our goal is to achieve sustainable growth and establish ourselves as a leader in bulk drugs, catering to various market segments. To achieve this objective, we are actively working on developing an agile operational system that is aligned with our goals. 

Impressions: 2583


#SpeakPharma with Metrochem
09 Oct 2023
“We want to emerge as the most trusted API firm in complex drug molecule segments”
This week, Speakpharma interviews Dr. Jagadeesh Babu Rangisetty, CEO of Biophore India Pharmaceuticals. The Hyderabad (India)-based company has four US Food and Drug Administration (FDA) and European Union inspected manufacturing facilities for active pharmaceutical ingredients (APIs) situated in Visakhapatnam, one dedicated intermediate facility and a world-class R&D lab housing 500 scientists with varied expertise. Now, the company hopes to emerge as the most trusted organization in the complex and niche pharmaceutical molecule segments. Excerpts:Can you provide an overview of Biophore’s expertise in developing complex APIs?Since our inception in 2007, Biophore has established itself as a company that focuses extensively on R&D to deliver exceptional value and end-to-end solutions to our clients.In 2010, we filed our first DMF (drug master file) in the US. Since then, we have successfully filed over 120 DMFs in the US and over 25 Certificates of Suitability (issued by the European Directorate for the Quality of Medicines), along with regulatory filings across Canada, China, Korea, Middle East and North Africa (MENA) and other global markets. Over the past five years, we have consistently ranked among the top 5 DMF filers.Our primary focus is to leverage our research strength and deliver products with complex chemistry and high entry barriers to our clients.  Over the years, we have developed such an expertise in niche and complex products and our customers look to us when it comes to critical products.We operate four world-class facilities that allow us to cover a wide range of therapeutic areas. Currently, Biophore serves over 300 customers, including several top 20 pharmaceutical companies.Can you explain the role of Biophore’s state-of-the-art technology development center in development of these products?Our state-of-the-art technology development center, situated in Hyderabad (India), plays a central role in advancing the development of niche pharmaceutical products. It serves as a research and innovation hub, allowing us to generate new ideas, work on them and deliver a robust product fit for the global markets.The center is equipped with specialized laboratories for various therapeutic segments, such as peptides and oncology products and also has sophisticated analytical instruments that facilitates complex API characterizations. Our dedicated research team is working on over 20 development projects at any given time.What are some of the key therapeutic areas that Biophore focuses on?Biophore focuses on several niche and complex therapeutic areas such as oncology, peptides, contrast media, colored APIs, hormonals, iron products, and injectable APIs. We have deep expertise in delivering time bound APIs to the market. We are also recognized as a global leader when it comes to products for orphan indications to provide treatment options for rare diseases.What are some of the challenges being faced by Biophore, and how does the company address them?The generic industry has been facing challenges of late due to various factors. These include intense price pressures, supply chain disruptions and increasing competition.To tackle these obstacles, we have implemented a range of strategies. One, we have adopted a backward integration approach for intermediates that gives us greater control over the supply chain and reduces our reliance on external sources. Two, rather than focusing on a single market for all our products, we target multiple global markets. This approach mitigates risks associated with market fluctuations and regulatory changes.Additionally, we place significant emphasis on delivering new and distinctive products. By offering a unique product portfolio, we set ourselves apart from our competitors, establish a competitive advantage and attract a broader customer base. 

Impressions: 2273


#SpeakPharma with Biophore
30 Sep 2023
“We owe our success to our focus on R&D, quality and better service”
This week, SpeakPharma interviews Ella Qu, General Manager & Director at China-headquartered Boai NKY Pharmaceuticals Limited, one of the world’s largest manufacturers of polypyrrolidone (PVP) and PVM/MA copolymer. While PVP is extensively used in the pharmaceutical industry as a binder in tablet manufacturing, PVM/MA copolymer is widely used in the cosmetic industry. In this interview, Ms. Qu talks about the company’s history, its product range and commitment to adopting green manufacturing practices. Excerpts:Can you tell us a bit about Boai NKY Pharma — its genesis, specializations and growth trajectory?Boai NKY Pharmaceuticals Limited was established in 1987. Back then, it was the first domestic company to develop and manufacture polyvinylpyrrolidone (PVP), a versatile ingredient used in pharmaceutical and cosmetic industries. In 2003, we got converted into a shareholding company.Innovation has been key to our growth strategy. In 2008, we researched and developed PVM/MA copolymer products. PVM/MA copolymer is an ingredient commonly used in oral care products such as denture adhesive, toothpaste, and can also be used in pharmaceutical applications.During the same period, we set up Tianjin Boai NKY International Limited, a whole share subsidiary company of Boai NKY. It operates all our international business.In 2010, we were publicly listed on the Shenzhen Stock Exchange. In 2015, we were certified by EXCiPACT GMP, a certification accepted by all major regulators around the world. In fact, we were the first manufacturer in China to obtain this certification. And in May this year, NKY Pharma became one of the largest PVP producers in the world and one of the largest producers of PVM/MA products in the world.What have been the reasons behind this success?NKY Pharma has always been dedicated to research and development. We have continuously worked towards introducing professionals in our company, and have strived to improve quality, to provide better service, to be more transparent and open to our customers.I attribute our success to these factors, and to our customers. Our aim has always been to establish mutually beneficial partner relationships. Going forward, our strong customer support coupled with our development in products and processes will stand us in good stead.How are you addressing the needs of customers spread across continents?Boai NKY Pharma has established its subsidiaries in Europe and the US. With the setting up of branch offices and warehouses, Boai NKY Pharma is able to communicate with its customers in a timely and effective manner.Could you provide more information about your product line, particularly KoVidone® and PolyKoVidone® lines of pharmaceutical excipients?KoVidone® and PolyKoVidone® polyvinylpyrrolidone (PVP) are widely used in the pharmaceutical field as excipients and are suitable for a broad range of dosage forms. KoVidone® K series products possess excellent binding, film-forming, dispersing and thickening properties and are widely used in the following dosage forms:• As a binder: These products are suitable for wet and dry granulation and direct compression in tableting. KoVidone® K improves particle compressibility and can be added to powder blends in dry or granulated forms through the addition of water, alcohol or hydro-alcoholic solutions.• As a solubilizer: These products are suitable for oral and parenteral formulations, enhancing the solubility of poorly soluble drugs in solid dispersion forms.• As a coating agent or binder: These products are suitable for coating of active pharmaceutical ingredients (APIs).• As a suspending, stabilizing or viscosity-modifying agent: These products are suitable for topical and oral suspension and solution applications. The solubility of poorly soluble drugs can be enhanced through the use of KoVidone®.KoVidone® also works as a viscosity modifier in tablet coatings.  The addition of KoVidone® K30 to HPMC (hydroxypropyl methylcellulose) formulated film coating solutions can effectively reduce the viscosity of the HPMC solution while not affecting the resultant hydration profile of the resultant film.PolyKoVidone® possesses dual binding and disintegration properties, and enhances active solubilization. The product is used in the following applications: • Super disintegrant: Due to its excellent swelling characteristics in water, PolyKoVidone® can be used as a water-insoluble disintegrant for wet and dry granulation processes. The material can be added either before or after granulation in direct compression tableting processes. It exhibits high capillary activity and pronounced hydration capacity, without the formation of gel.• Solubility enhancer: PolyKovidone® increases the solubility of poorly soluble drugs via co-evaporation processes.• Suspension stabilizer: PolyKoVidone® increases viscosity and improves the dispersion properties to reduce the sedimentation rate of drugs, while increasing the re-dispersibility of said sediment. It is suitable for liquid and instant oral preparations.• Complexing agent of drug ingredients: PolyKoVidone® stabilizes active ingredients in pharmaceutical products, thereby improving drug solubility and bioavailability.How is Boai NKY Pharma committed to the development of green production processes?As a young company, the top management of Boai NKY Pharma has laid out a long-term planning and development strategy. We follow all environmental compliances mandated by the government.We are working towards making our production processes green through ways such as real time monitoring of waste streams, 100 percent recycling of processing water, and by switching from coal to natural gas.We are working with associations that are dedicated to sustainable development. Our growth and developmental goals will always be aligned with our commitment to environmental sustainability. 

Impressions: 1818


#SpeakPharma with Boai NKY
27 Sep 2023
“Polpharma has invested over €35 million in a new facility to handle HPAPIs”
Over the recent years, the market for contract development and manufacturing organizations (CDMOs) has been growing at a fast clip owing to a plethora of factors such as the rising demand for biologics, new trends towards personalized medicines and the need to bring new treatments to the market more quickly. This week, SpeakPharma interviews Dawid Ignatowicz, Head of Key Account Management, CDMO, Polpharma, to know how the Polish drugmaker is growing its CDMO business and some of the inherent advantages it enjoys in this landscape. Of late, there has been an increase in demand for drug substance development and cGMP manufacturing services. How is Polpharma gearing up to meet this demand? In fact, the number of drug developments has increased over the past few years.  This coupled with some lack of capacity in some major European CDMO’s, potentiates good opportunities for companies like Polpharma. Over the last few years, Polpharma has been growing its offer on the CDMO, either by adding new capabilities in research and development and in production or by increasing its manufacturing standards (compliance, EHS, etc.).  Our objective is to support our customers into the different phases of drug development, as such we have adapted our systems to be able to answer their requirements on the different stages – with the ultimate goal of providing a reliable, efficient, and cost-effective service to the customers.  What differentiates Polpharma from other CDMOs? Our major strengths can be referred as: good project management skills (we have a group of experienced people that help the customers), transparency (since the inception of a project we have developed a clear and transparent way of communicating flow with the customer so that we can have full visibility of their project in our site), an ability to listen to our customers (a rather simple requirement, but that seems difficult to find in the market), good process design (more delivery kilos of a product we want to establish a good efficient and cost-effective process) and flexibility (we understand that development projects could have changes on the timelines and the capability to adapt to those changes is critical). Besides the above, we have a positive track record of regulatory approvals coupled with experience and expertise in filing to the FDA. We have positive pre-approval inspection audits (PAIs) that reaffirm our robust quality management system. We are known for efficient management of changes and deviations — we are both open and collaborative and work alongside our clients. Tell us about the range of CDMO projects that Polpharma handles. Owing to our decades-long experience in drug substance development, regulatory filing, and commercial manufacturing, Polpharma can support customers at various phases — from clinical supplies, through validation and launch, up to regular commercial supplies. Manufacturing highly potent APIs comes with several challenges, especially with respect to toxicity and exposure. Are you observing more projects with high toxicity? In order to address the growing demand for the development and manufacture of highly active compounds, we have invested over €35 million in a new facility to handle HPAPIs that will include process and analytical R&D, small-scale cGMP manufacturing suites and quality control (QC) labs. This facility will allow us to handle compounds with an occupational exposure limit (OEL) value down to 10 ng/m3 (or OEB6, i.e. very high contamination).  

Impressions: 2300


#SpeakPharma with Polpharma
11 Sep 2023
“We are diversifying by expanding our manufacturing partnerships in China & India”
This week, SpeakPharma interviews Peter Werth, President and CEO of ChemWerth, a full-service generic drug development and supply firm that is celebrating its 40th year in business. On this milestone anniversary, Werth discusses the drugmaker’s plans to expand its manufacturing partnerships in China and India. These investments will further diversify its supply and portfolio, help develop new generic APIs, mitigate the risk of supply chain disruptions, and position ChemWerth to meet the increasing global demand for generic pharmaceuticals, says Werth. Excerpts:With ChemWerth turning 40, what are your thoughts on the company’s journey?We have had an interesting journey thus far. After being founded in 1983, we filed our first Drug Master File (DMF) with the US Food and Drug Administration (FDA) in 1987. We have come a long way since then, having established ourselves as specialists in product selection and development, analytical and regulatory services, as well as project management.Today, we are a leading supplier of generic active pharmaceutical ingredients (APIs) for human and animal health markets worldwide, with a presence in 38 countries. We have access to over 500 APIs from more than 30 manufacturing facilities worldwide. We also act as a regulatory agent for more than 25 facilities approved by the FDA in the US, Europe, India, and China. We have partnerships in several countries and sell more than 100 products worldwide.The year 2020 was a landmark year for us, as we filed our 500th DMF with the FDA. It strengthened our position as one of the world leaders in filing DMFs. Our average review cycle for DMF filings is just 0.79, which is much lower than the industry average of 2.5 cycles. This allows our customers to reach the market much faster, which in turn gives them a substantial competitive advantage over their competitors.With our reputation for supplying reliable, high-quality, non-infringing APIs at competitive prices, we have earned the trust of some of the largest generic pharmaceutical companies. Our continued growth and success are the result of our commitment to quality, our exceptional regulatory services, and our ability to adapt to changes in the pharmaceutical industry.In this year of our 40th anniversary, we’re entering an exciting period of growth. We are expanding our manufacturing footprint worldwide.Can you elaborate on these expansion plans?We have decided to invest millions of dollars in expanding our manufacturing partnerships in China and India. This will help us diversify our portfolio as well as our supply chain.Through our investments in our joint-venture facilities in India and China, we want to show our commitment towards delivering affordable medicines to patients all around the world. This expansion will also help us develop new generic APIs, mitigate the risk of supply chain disruptions, and meet the increasing demand for generic medicines worldwide.All our partner manufacturers that currently produce steroid, hormone and veterinary products and large-volume APIs and small-molecule inhibitors will benefit from the new investments. We will also create new jobs for highly skilled workers such as scientists, engineers, and manufacturing personnel.In addition to hiring employees, these investments will cover training that is required to raise compliance and quality to current good manufacturing practice (CGMP) standards and will be used to purchase new equipment.What’s the growth rate of the global generic drug market? How is ChemWerth planning to capitalize on this growth?The global generic drugs market is growing at a healthy pace. According to Precedence Research, a company that provides strategic market insights, the global market for generic drugs is poised to grow at a compounded annual growth rate (CAGR) of 5.4 percent, growing from US$ 439.37 billion in 2022 to US$ 670.82 billion by 2030. There are several factors contributing to this growth, such as the low cost of generics, expiration of patents of branded drugs, and increasing prevalence of chronic diseases.The pandemic led to supply chain disruptions that created drug shortages worldwide. How did ChemWerth mitigate the risk of supply chain disruptions?Yes, the pandemic was marked by supply chain disruptions that drove demand to unprecedented highs. During those days, ChemWerth relied on its experience and expertise in working with the FDA in order to gain necessary approvals and get the products on the market quickly. Our experienced team worked tirelessly to ensure that the supply of essential drugs was maintained, new drugs were developed to address emerging needs, and compliance remained at a high level.We monitored the global supply chain very closely, developed contingency plans, and diversified our manufacturing partnerships to reduce the risk of supply chain disruptions. As a result of these efforts, we successfully met the increased demand for pharmaceuticals during the pandemic and continued to deliver high-quality, affordable drugs to patients worldwide.At ChemWerth, we have a highly experienced team of regulatory and compliance experts who work closely with the FDA to ensure successful DMF approvals. We are proud of our track record of routinely gaining DMF approvals on the first pass. This places us among the best-in-class companies that are in the 12 percent approval group.In the future too, we intend to work on mitigating supply chain disruptions and provide high-quality generic pharmaceutical products to patients worldwide. 

Impressions: 2585


#SpeakPharma with ChemWerth
02 Jun 2023
“Quotient Sciences’ integrated approach to drug development accelerates molecules to IND & beyond”
This week, SpeakPharma interviews Eleanor Row, Executive Director of Commercial at Quotient Sciences, a global drug development accelerator with state-of-the-art development, manufacturing and clinical testing facilities in the US and UK. Over the last 30 years, Quotient has worked on over 3,000 molecules across all stages of development. Row discusses the challenges and considerations that drug developers should be aware of when trying to quickly get their molecule from discovery to investigational new drug (IND) stage and onward into the clinic. While throwing light on the different development functions at an early stage of drug development, she also talks about how an integrated approach can help accelerate a molecule’s pathway to IND and beyond.What are the main challenges that drug developers face today in getting their molecules IND-ready?When transitioning from discovery to IND, there are many challenges that drug developers can face. The first challenge in any drug development program is to select the best molecule from various potential leads. During this stage, lead candidates are evaluated based on their early biopharmaceutical ‘developability’, in vitro activity, and their ability to demonstrate acceptable specificity and selectivity for the biological target of the desired therapeutic area.Once a solid lead candidate is selected, the next goal is to complete all necessary drug product development and safety studies that will support regulatory approval to begin a first-in-human (FIH) phase 1 clinical trial.In addition to exhibiting an acceptable pharmacokinetic (PK) profile and demonstrating in vivo efficacy, it is crucial to show that the drug has a good safety pharmacology margin with an acceptable drug-drug interaction (DDI) profile. Access to increasing quantities of drug substance becomes even more critical at this stage, and the focus shifts from synthesizing small quantities of material from medicinal chemistry routes to developing a scalable synthetic process (PR&D) and providing the first kilogram of Good Manufacturing Practice (GMP)-grade material suitable for early clinical development.What should drug substance decision-makers be considering at this stage?While developing a drug substance manufacturing process, it is crucial to optimize the synthetic route early on. Any changes to the route at a later stage can be time consuming, costly and may require additional bridging toxicology studies due to differences in the impurity profile.Designing a synthetic process that is robust and commercially scalable helps avoid common pitfalls that can add risk to material supply. During this stage, it is important to minimize the number of steps (either by telescoping or identifying commercially available starting materials with a robust supply chain), develop simple strategies for purification and isolation, and eliminate the use of any hazardous reagents or intermediates, particularly genotoxic impurities (GTIs).During the process of developing a drug substance, it is important to take into account the impurities that are produced along with the substance. Impurities can be easily identified and quantified by performing analytical method development alongside synthesis. This provides a good understanding of the fate of impurities and control points within the drug substance synthesis at an early stage and helps reduce development timelines. Non-GMP demonstration batches can be manufactured as soon as the synthetic methodology is available. Once material is available, stability studies can be initiated to support the clinical shelf life and pivotal data for the CMC dossier submission.It is also crucial to have a long-term regulatory strategy and to identify potential GMP starting materials appropriate to the development stage. Regulatory starting materials (RSMs) should be chosen to allow enough stages to be performed under GMP to demonstrate control over the drug substance’s quality. Changing the API at a later stage in clinical development to meet the increased regulatory requirements may cause additional costs, risks and delays, as additional clinical studies may be needed to prove that changes in the starting materials do not change the toxicology or impurity profiles of the final material.Finally, the selection of the right physical form is often overlooked during early development. Making the right decisions early on can lead to a more robust drug substance isolation strategy and formulation to take into the clinic, resulting in reduced drug product development timelines. Defining the desired salt form or free form of the molecule earlier in the project also brings with it the advantage of doing away with the need of bridging toxicology or stability studies further downstream. It can also lead to a much stronger intellectual property (IP) position.What considerations should formulation and clinical manufacturing teams be aware of at this stage of dosage form development?Understanding the physical form and behavior of a molecule is crucial for designing a suitable formulation for the clinic. Technology selection is determined by the solubility and permeability of a molecule, utilizing the Developability Classification System (DCS) or the Bioavailability Classification System (BCS). Providing the data sooner to the formulators can significantly reduce the lead time to a clinic-ready formulation. The use of a simple, fit-for-purpose formulation during an early clinical evaluation program is a tried and tested solution that offers significant time and cost benefits compared to alternative strategies. This approach also provides flexibility for dosing administration during early clinical studies since dosing regimens are not fully defined at this stage.Why is it beneficial for chemistry, CMC and clinical groups to be engaged with one another in early development?Typically, drug substance, drug product, and clinical testing activities are conducted by different organizations. This is a classic approach, but it is time consuming and costly, leading to poor knowledge and material transfer between organizations and increasing the risk of program delays.At Quotient Sciences, we offer a unique approach to drug development through our proprietary Translational Pharmaceutics platform. We have the unique ability to integrate drug substance, drug product, and clinical testing activities under a single organization and program manager. This enables process development, analytical, and formulation chemists to interact and work together from the beginning till the end of the project, ensuring data and drug substance information is shared between teams. As a result, activities that would typically begin after the completion of the drug substance program can begin several months earlier.Using this integrated approach, we can reduce drug development timelines in the candidate development stage by an average of three to six months, which translates into significant R&D cost savings. Our collective experience of over 15 years and 500 Translational Pharmaceutics programs ensures a smooth review by regulators, accelerating clinical trial approval. Our integrated approach significantly reduces drug development timelines from candidate selection to clinical development, reducing the overall program risk and enhancing the likelihood of downstream clinical and commercial success.What should clinical operations teams be aware of during early-stage development?As a molecule approaches IND transition, there are several unknowns that can affect its future success in downstream development and clinical trials. Success in the clinic is often linked to the early establishment of efficacy and the current trend of including patient investigations in the first clinical protocol. However, this approach has several factors that can impact the program’s timeline, such as patient population size for recruitment and resource constraints. Implementing such a study design can often result in a significant delay in the first dose in human milestone, which is critical to confirming real drug exposures that will ultimately drive the efficacy question.Leveraging a healthy volunteer study can help clinical operations teams focus their attention on answering immediate questions about their molecule’s development. This approach allows clinical teams to keep an eye on future pivotal efficacy investigations without delaying the collection of decision-making data.How can an integrated program help accelerate the pathway to IND?When drug developers move from drug discovery to pre-clinical and clinical development, one of the challenges they face is splitting their program across multiple service providers. This places the burden of project management on them and creates gaps in the development timeline, leading to limited knowledge and material sharing as well as adding time and cost to the program. Quotient Sciences’ Translational Pharmaceutics platform lets customers benefit from holistic scientific advice. Our projects are data-driven and scientific, and are led by multi-disciplinary project teams with expertise in CMC, clinical and biopharmaceutics.Through tight integration of early development activities under a single organization, Quotient Sciences breaks down traditional industry silos, accelerating timelines and reducing risks. Customers not only benefit from the time and cost savings that Quotient Sciences and our Translational Pharmaceutics platform provide for their programs, but they also meet the end-goal of getting new medicines to patients faster. 

Impressions: 1470


#SpeakPharma with Quotient Sciences
15 May 2023
“Centrient is at the forefront of sustainable pharmaceutical manufacturing”
One of the most pressing problems today is environmental pollution. Every year, the world comes together on April 22 to celebrate Earth Day. This year’s Earth Day calls on governments, institutions, businesses, and citizens to invest in the planet by addressing the issues of climate change, air and water pollution, deforestation, and plastic overconsumption. According to the World Health Organization (WHO), healthier environments can prevent almost a quarter of the world’s disease burden.This week, SpeakPharma spoke to Manjit Singh, Director for Corporate Sustainability at Centrient Pharmaceuticals, a global B2B leader in sustainable, enzymatic antibiotics, next-generation statins and anti-fungals, about sustainable manufacturing. Excerpts:How are pharma companies addressing the issue of environmental sustainability? What goals have you set for reducing your environmental impact?The global pharma industry is a major polluter. During the past decade, the intensity of greenhouse gas emissions generated by the pharma industry was approximately 55 percent greater than that of the automotive industry. The industry must work together to systematically consider the environmental impact of the products it manufactures.Today, many companies incorporate carbon emissions reduction, responsible waste and water management, and renewable energy sourcing as core environmental, social, and governance (ESG) goals. The growing demand for environmental sustainability also affects pharmaceutical companies’ supply chains and procurement practices.One of the biggest environmental issues we face as a society is CO2 emissions. It’s a major focus area for many companies. At Centrient, we have set a goal of reducing our carbon emission intensity by 50 percent by 2030 through increased reliance on renewable energy. We are committed to going through third-party assessments and ratings like EcoVadis and SBTi (Science Based Targets initiative) to be transparent about our progress towards emissions reduction targets.Another key issue is wastewater management. Pharmaceutical manufacturing, particularly antibiotic production, is a highly water-intensive process. We produce all our antibiotics using a proprietary enzymatic process. This process requires less water and energy and doesn’t use chemical solvents or other harmful substances.What is antimicrobial resistance, and how does it affect human health and the environment?Antimicrobial resistance or AMR occurs when bacteria, viruses, fungi, and parasites change over time and stop responding to medicines. Antibiotics and other antimicrobial drugs become ineffective, and infections become increasingly difficult or impossible to treat, making routine medical procedures, such as surgery — including C-sections, hip replacements, and organ transplantations — riskier. For example, AMR is the second leading cause of death in cancer patients.The WHO currently lists AMR among the top 10 threats to global health. By 2050, up to 10 million deaths could occur annually due to AMR.When it comes to pharmaceutical manufacturing, release of antibiotics in high concentrations from manufacturing sites can contribute to new forms of resistance in pathogens. In 2016, we became one of the first pharmaceutical companies to begin the continuous, year-round monitoring of antimicrobial activities in wastewater at all our sites in Europe and beyond. Since then, we have developed an innovative way of detecting very low antibiotic activity levels – as low as 50 parts per billion – in wastewater. In May 2022, we became the first pharma company to meet the stringent PNEC (short for Predicted No-Effect Concentration) discharge targets for our complete oral antibiotics product range and their supply chains. The final step in this process will be to obtain an external PNEC certification.We are one of the first companies to participate in a pilot certification scheme designed by the British Standards Institution (BSI) in collaboration with the AMR Industry Alliance.As a former chair of the Pharmaceutical Supply Chain Initiative (PSCI), what’s your view on the recent developments in sustainable procurement?Along with responsible manufacturing, the industry must ensure that the procured raw materials come from cleaner sources. Some European governmental agencies already incentivize responsible manufacturing and compliance while procuring antibiotics from suppliers. For example, at Centrient, our suppliers are assessed by PSCI-approved audit firms and in-house assessments. This covers labor and human rights, ethics, health and safety, the environment, and management systems.What are your sustainability tips for Earth Day?To make a positive impact on Earth Day, individuals can clean up their communities, plant more trees, reduce the use of plastic, and reuse and recycle more things. Similarly, manufacturers must consider the negative impact of their operations on the environment and make sustainability a part of their business strategy.At Centrient, our sustainability efforts are geared towards creating value for all our stakeholders, driving sustainable growth with our customers, and creating a more sustainable world for future generations. 

Impressions: 2158


#SpeakPharma with Centrient Pharmaceuticals
21 Apr 2023